Devices
FDA says the Teleflex 8/26 recall of 60,000 Iso-Gard Filter S products is Class 1. An agency notice says the breathing circuit bacterial filters are connected to respiratory equipment or breathing systems in intensive care units and operating rooms. The recalled units were distributed between 9/1/
Devices
Cardiac surgeon Hooman Noorchashm, known to FDA for his opposition to power morcellation, has petitioned the agency asking it to change the classification of Becton Dickinson’s (BD) poly 4-hydroxybutyrate (P4HB)-based Phasix and GalaFlex products from medical devices to biologicals so that they undergo proper clinical safety and
Devices
FDA has revised the authorized uses for, and is requiring updates to product labeling regarding repeat, or serial, testing, for all currently authorized SARS-CoV-2 antigen tests. An 11/1 revised “Letter of Authorization” creates one additional Condition of Authorization and also eliminates an earlier condition that it says
Devices
FDA is recommending that health care providers discuss alternative magnetic resonance imaging (MRI)-guided breast biopsy options for patients if facilities are unable to perform these due to a shortage of Philips Invivo MRI breast biopsy grid plates and other Philips Invivo MRI disposables. Late last month, Philips issued a
Devices
FDA is alerting patients and health care providers about a shortage of tracheostomy tubes, including Bivona tracheostomy tubes manufactured by ICU Medical. “A shortage of Bivona tracheostomy tubes is more likely to impact pediatric patients because the supply of alternative tubes with similar functionality may be limited,” an agency notice
Devices
FDA has cleared a Fresenius Medical 510(k) to implement changes to its 2008T hemodialysis machines that include use of modified silicone tubing in the hydraulics of the machine, specifically platinum catalyst silicone tubing. The clearance addresses certain machines that FDA warned about earlier this year about the potential risk
Devices
A California state court has upheld PMA preemption in a case involving a Medtronic spinal cord stimulator. Attorney Michelle Yeary (Dechert) writes in the Drug and Device Law blog that the plaintiff in the case brought claims for strict liability, failure to warn, negligence, and negligent misrepresentation. Yeary says Medtronic
Devices
The CDRH Digital Health Center of Excellence has published “Spotlight: Digital Health Regulatory Science Opportunities” highlighting important research areas identified by FDA and external stakeholders. The document describes the current regulatory science areas of interest in digital health for stakeholders to consider. “Advances in digital health occur rapidly,” CDRH says,
Devices
FDA says Baxter International issued 10/21 an urgent medical device correction for its WatchCare incontinence management system due to the potential for radio frequency interference with other medical devices. An agency notice says that to date, interference in all cases but two occurred at distances less than one meter.
Devices
FDA has published a guidance, Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions, to help agency staff develop a request for additional information needed to decide on a medical device marketing application under the “least burdensome” provisions of the Federal Food, Drug, and Cosmetic Act. FDA
Devices
The Medical Device Innovation Consortium (MDIC) has published its first industry benchmark report assessing the cybersecurity maturity of the medical technology industry. The report was prepared by Booz Allen under a 4/2021 contract with MDIC. It ranks survey responses from medical device manufacturers on the Healthcare Sector Coordinating Councils’
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Speaking at the 10/25 AdvaMed Medtech Conference, FDA commissioner Robert Califf said his preference would be for Congress to pass legislation on the regulation of laboratory-developed tests (LDTs). Asked how he would respond if Congress fails to act, Califf said, “That’s a tough question. You know, it’
Devices
FDA has cleared a NeuroOne Medical Technologies 510(k) to market its Evo sEEG Electrode technology for temporary (less than 30 days) use with equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain. “As opposed to cortical electrodes, sEEG electrodes provide a
Devices
FDA has granted Intelligent Ultrasound a de novo marketing authorization for its artificial intelligence (AI) ScanNav Anatomy Peripheral Nerve Block. The company says the device uses the latest AI technology to assist healthcare professionals in identifying and labeling anatomy in live ultrasound images in preparation for ultrasound-guided regional anesthesia.
Devices
FDA has closed out a Warning Letter issued to Innova Medical Group in 2021 that cited its SARS-CoV-2 Antigen Rapid Qualitative Test because it was being marketed without approval, clearance, or authorization from the agency. The letter was issued following two FDA inspections (see earlier story), which also
Devices
FDA has approved expanded labeling on Medtronic’s SelectSecure MRI SureScan Model 3830 cardiac lead for conduction system pacing, which the company says “taps into the heart’s natural electrical system, giving patients needed therapy while avoiding complications sometimes associated with traditional pacing methods, such as cardiomyopathy.” The company says
Devices
University of Michigan professor Kevin Fu, who was the CDRH acting director of medical device cybersecurity, says companies don’t have to wait for FDA to finalize its guidance before starting to develop and submit software bills of materials (SBOM). In an interview posted in a ReversingLabs blog, Fu says
Devices
FDA has published a draft guidance, Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare, to propose select updates to the Breakthrough Devices Program guidance. The document says the existing guidance remains in use in its current form until this draft is finalized. “FDA intends
Devices
FDA has closed its post-approval study requirements for Abiomed PMA for its Impella heart pumps. As a result, the company says the agency has affirmed that the pumps are safe and effective for cardiogenic shock, high-risk percutaneous coronary intervention (PCI), post-cardiotomy cardiogenic shock, cardiogenic shock in the
Devices
FDA says the Philips Respironics 8/2 recall of 18,670,643 select masks for BiPAP and CPAP machines is Class 1. Philips says the devices were distributed between 1/1/2015 and 9/9/2022. An FDA notice says they were recalled due to a “serious safety concern” involving
Devices
FDA is reminding the medical device industry and unique device identifier (UDI) stakeholders that the 5/2021 guidance on enforcement policy regarding the use of National Health Related Item Code and National Drug Code numbers on device labels and packages applies only to devices labeled before 9/24/23. An
Devices
A 3/28-4/4 FDA inspection at Forcemech International, Pearland, TX, determined that the firm is a manufacturer (repackager/relabeler) and initial distributor/importer of the Forcemech Navigator and Navigator XL powered wheelchairs. A 9/21 Warning Letter says the devices are adulterated due to Quality System Regulation violations.